Study Documents
You can find and download PreVent-ACaLL study related document below.
If you have further questions please contact principal investigator Carsten Utoft Niemann, MD, PhD, carsten.utoft.niemann@regionh.dk or chip-prevent.rigshospitalet@regionh.dk.
- PreVent-ACaLL Protocol v2.0
- PreVent-ACaLL Amendment to Protocol v2.0
- PreVent-ACaLL Informed Consent Master v3.0 (English)
- PreVent-ACaLL Informed Consent Prescreening Master v2.0 (English)
- PreVent-ACaLL Schedule of Assessments v5.0
- PreVent-ACaLL Laboratory Manual for sites v4.0
- PreVent-ACaLL Laboratory Manual for local central labs v3.0
- PreVent-ACaLL Pharmacy Manual v4.0
- PreVent-ACaLL REDCap Guide v3.0
- PreVent-ACaLL Initiation Flowchart
- PreVent-ACaLL Instruction - Pre-screening, screening and randomization
- PreVent-ACaLL Instruction - Enrollment procedure
- PreVent-ACaLL Instruction - Collection of study samples
- PreVent-ACaLL Instruction - How to handle AE and SAEs v2.0
- PreVent-ACaLL Instruction - Reporting of protocol deviations
- IWCLL Guideline (Hallek et al. 2018)
- CTCAE (latest version)